Form 8-K
8-K — Entera Bio Ltd.
Accession: 0001178913-26-004720
Filed: 2026-10-06
Period: 2026-10-06
CIK: 0001638097
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — zk2636199.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (exhibit_99-1.htm)
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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 6, 2026
Entera Bio Ltd.
(Exact Name of Registrant as Specified in Its Charter)
Israel
001-38556
Not Applicable
(State or other jurisdiction
of incorporation)
(Commission File Number)
(I.R.S. Employer
Identification)
Kiryat Hadassah, Minrav Building – Fifth
Floor, Jerusalem, Israel 9112002
(Address of principal executive offices) (Zip Code)
+972-2-532-7151
(Registrant’s Telephone Number, Including
Area Code)
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Ordinary Shares, par value of NIS 0.0000769
ENTX
Nasdaq Capital Market
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Appointment of Laura Hamill as Director
On October 6, 2026, the Board of Directors (the
“Board”) of Entera Bio Ltd., a company organized under the laws of the State of Israel (the “Company”),
appointed Laura Hamill as a Class I director of the Company, effective December 1, 2026. Ms. Hamill will serve as a director until the
Company’s 2027 Annual Meeting of Shareholders and until her successor shall have been elected and qualified, or until her earlier
death, resignation, retirement, disqualification or removal. Ms. Hamill has also been appointed to serve as a member of both the audit
committee and corporate governance and nomination committee of the Board, in each case, effective December 1, 2026.
Ms. Hamill, age 62, is a seasoned biopharmaceutical
executive with more than 35 years of commercial leadership experience. She most recently served as Executive Vice President, Worldwide
Commercial Operations at Gilead Sciences, Inc. Prior to Gilead, Ms. Hamill spent nearly two decades at Amgen Inc. in roles of increasing
scope, including Senior Vice President of U.S. Commercial Business Operations and Senior Vice President of the Intercontinental Region.
Earlier at Amgen, she held leadership roles including Vice President of International Marketing and Business Operations in Switzerland,
Vice President of U.S. Corporate Accounts and Reimbursement, and served as executive leader of Amgen’s Senior Women’s Advisory
Council. Ms. Hamill currently serves on the Board of Directors of Jazz Pharmaceuticals plc (Nasdaq: JAZZ), BB Biotech AG, and Fate Therapeutics,
Inc. (Nasdaq: FATE). She previously served on the boards of Acceleron Pharma Inc. (acquired by Merck & Co.), Pardes Biosciences and
Y-mAbs Therapeutics, Inc. Ms. Hamill holds a Bachelor of Business Administration with an emphasis in marketing from the University of
Arizona.
There are no arrangements or understandings between
Ms. Hamill and any other person pursuant to which Ms. Hamill was appointed as a director of the Company. The Board has determined that
Ms. Hamill is independent under the applicable rules of the Securities and Exchange Commission and the Nasdaq Stock Market.
Since the beginning of Company’s last fiscal
year, the Company has not engaged in any transaction, or any currently proposed transaction, in which Ms. Hamill had or will have a direct
or indirect material interest that would require disclosure pursuant to Item 404(a) of Regulation S-K.
Ms. Hamill will participate in the Company’s
standard non-employee director compensation arrangements, which were most recently approved by the Company’s shareholders in July
2026, including the right to annual cash payments with respect to Board and applicable committee service and annual equity grants under
the Company’s 2018 Equity Incentive Plan.
Departure of Director
On October 6, 2026, Yonatan Malca notified the
Board that he would step down as a director, effective December 1, 2026. Mr. Malca’s departure from the Board was not the result
of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.
Item 7.01 Regulation FD Disclosure.
On October 6, 2026, the Company issued a press
release announcing the appointment of Ms. Hamill to the Board. A copy of the press release is furnished as Exhibit 99.1 hereto and incorporated
by reference herein.
The information disclosed under this Item 7.01,
including in Exhibit 99.1 attached hereto, is “furnished” and not “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such
information shall not be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended,
except to the extent such other filing specifically incorporates such information by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
Description
99.1
Press release, dated October 6, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ENTERA BIO LTD.
Date: October 6, 2026
By:
/s/ Miranda Toledano
Name: Miranda Toledano
Title: Chief Executive Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: exhibit_99-1.htm · Sequence: 2
Exhibit 99.1
Entera
Appoints Global BioPharma Executive Laura Hamill to Its Board of Directors, Expanding Commercial Expertise
Former Gilead
and Amgen executive joins Entera with over 35 years of experience advancing and commercializing impactful and blockbuster therapies
TEL
AVIV, Israel, October 6, 2026 -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the
development of oral peptides, today announced the appointment of biopharmaceutical executive Laura Hamill to its Board of Directors,
effective December 1, 2026. Ms. Hamill brings more than 35 years of global commercial, market access and business leadership experience
across multiple therapeutic areas. She succeeds Yonatan Malca, who is stepping down from the Board.
“I
am delighted to welcome Laura to our Board as Entera enters an important new chapter of late-stage clinical execution, commercial preparedness
for EB613 and advancement of our broader pipeline,” said Miranda Toledano, Chief Executive Officer of Entera. “Laura is an
exceptional leader with vast experience stewarding multi-billion dollar global therapeutic franchises. Her perspective will be invaluable
as we think strategically about the potential of EB613 and our oral peptide platform.” “I would also like to express my sincere
gratitude to Yonatan for his 16 years of dedicated service to Entera,” Ms. Toledano continued. “His leadership and commitment
have helped guide the Company from its inception through a period of meaningful growth and transformation.”
“Entera
has built a unique oral peptide pipeline with the potential to transform how important therapies are delivered to patients,” said
Ms. Hamill. “I am particularly inspired by the potential of EB613 in osteoporosis and the opportunity to help millions of women
preserve their bone health and maintain active, vibrant lives. I am excited to join the Board at this important stage and support Entera
as it works to advance EB613 and realize the broader potential of Entera’s oral peptide platform.”
Ms.
Hamill is a seasoned biopharmaceutical executive with more than 35 years of global commercial leadership experience spanning product
launches, global franchise development, market access and payer strategy. Most recently, she served as Executive Vice President, Worldwide
Commercial Operations at Gilead Sciences, Inc., where she led an organization of approximately 2,500 employees responsible for $22 billion
in annual revenue and oversaw the transformation of the company's global commercial operations. Prior to Gilead, Ms. Hamill spent nearly
two decades at Amgen Inc. in leadership roles of increasing scope. As Senior Vice President of U.S. Commercial Business Operations, she
led commercial activities and supporting functions across Amgen's therapeutic areas, representing approximately 80% of Amgen’s
revenue. She previously served as Senior Vice President of Amgen's Intercontinental Region, overseeing 26 countries worldwide. Earlier
in her Amgen career, she held leadership roles including Vice President of International Marketing and Business Operations in Switzerland
and Vice President of U.S. Corporate Accounts and Reimbursement. Ms. Hamill currently serves on the Boards of Directors of Jazz Pharmaceuticals
plc (Nasdaq: JAZZ), BB Biotech AG and Fate Therapeutics, Inc. (Nasdaq: FATE). She previously served on the boards of Acceleron Pharma
Inc., Pardes Biosciences and Y-mAbs Therapeutics, Inc. Ms. Hamill holds a Bachelor of Business Administration in Marketing from the University
of Arizona.
About Entera
Entera
is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs
where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology
platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate,
EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled,
dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera
is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612),
the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and
the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short
bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn,
Twitter, and Facebook.
Cautionary Statement
Regarding Forward Looking Statements
Various
statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans,
financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational
results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,”
“could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,”
“might,” “objective,” “plan,” “predict,” “project,” “target,”
“likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions
or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes
in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or
results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause
actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes
in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from
and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing
of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential
disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and
laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide;
overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs
of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s
ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company
with limited operating history; Entera’s competitive position with respect to other products on the market or in development for
the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it
pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain
and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing
standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s
intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary
Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with
the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no
assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they
will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied
in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements
Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and
Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information,
future events or otherwise, except to the extent required by law.
Company Contact:
IR@enterabio.com
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